Round 1 - Foundation for Innovative New Diagnostics

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Figure 13: P. falciparum (P. falciparum test line*) false positive rate against Plasmodium spp. negative samples containing potentially cross-reacting blood immunological abnormalities or infectious pathogens † 50 False positive rate (%) 40 30 20 10 Non malaria infectious pathogens (HRP2) Immunological abnormalities (HRP2) Non malaria infectious pathogens (pLDH) Immunological abnormalities (pLDH) 0 ADVANCED QUALITY TM MALARIA (p.f) POCT ADVANCED QUALITY TM One Step Malaria (p.f.) Test (whole blood) Advantage Mal Card Advantage P.f. Malaria Card Advantage Pan Malaria Card AZOG Malaria pf (HRP-II) /pv (pLDH) Antigen Detection Test Device Binax Now Malaria CareStart Malaria HRP2 (Pf) CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO CareStart Malaria pLDH (PAN) First Response Malaria Ag Combo (PLDH/HRP2) First Response Malaria Ag HRP2 FirstSign – Malaria Pf Card Test FirstSign – ParaView-2 (Pv + Pf) Card Test Hexagon Malaria Hexagon Malaria Combi ICT Malaria Combo Cassette Test (ML02) ICT Malaria Pf Cassette Test (ML01) Immunoquick Malaria +4 Immunoquick Malaria Falciparum Malaria P.F/Vivax Malaria Plasmodium falciparum Rapid test Device (Whole blood) Malaria Rapid Combo Malaria Rapid Dual Malaria Rapid Pf Malascan Rapid Test for Malaria Pf/Pan (Device) One Step Malaria Antigen Strip OnSight – ParaQuick (Pan OptiMAL-IT Parabank Rapid Test for Malaria Pan (Device) Paracheck Pf Rapid test for P. falciparum Malaria (Device) Paracheck Pf Rapid test for P.falciparum Malaria (Dipstick) Parahit-f DIPSTICK FOR FALCIPARUM MALARIA Parahit-f TEST DEVICE FOR FALCIPARUM MALARIA Parahit-Total Device Rapid test for P. falciparum and Pan malarial species Parascreen Rapid Test for Malaria Pan/Pf (Device) Quickstick Malaria Antigen Test SD BIOLINE Malaria Ag SD BIOLINE Malaria Ag Pf SD BIOLINE Malaria Ag Pf/Pan Wondfo One Step Malaria Pf/Pan Whole Blood Test † - Phase 2 Evaluation Panel included 90 Plasmodium spp. negative samples - 42 clean negatives; 27 samples with blood immunological abnormalities and 21 with non Plasmodium spp. infectious pathogens. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl *- includes Pf specific lines on combination tests and pan-specific lines on pan-specific only products. 26 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008)
Figure 14: Plasmodium spp. (pan or P. vivax test line*) false positive rate against clean negatives † 50 False positive rate (%) 40 30 20 10 pLDH Aldolase pLDH + aldolase 0 Advantage Mal Card Advantage Pan Malaria Card AZOG Malaria pf (HRP-II) /pv (pLDH) Antigen Detection Test Device Binax Now Malaria CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO CareStart Malaria pLDH (PAN) First Response Malaria Ag Combo (PLDH/HRP2) FirstSign – ParaView-2 (Pv + Pf) Card Test Hexagon Malaria Combi ICT Malaria Combo Cassette Test (ML02) Immunoquick Malaria +4 Malaria P.F/Vivax Malaria Rapid Combo Malaria Rapid Dual Malascan Rapid Test for Malaria Pf/Pan (Device) One Step Malaria Antigen Strip OnSight – ParaQuick (Pan OptiMAL-IT Parabank Rapid Test for Malaria Pan (Device) Parahit-Total Device Rapid test for P. falciparum and Pan malarial species Parascreen Rapid Test for Malaria Pan/Pf (Device) Quickstick Malaria Antigen Test SD BIOLINE Malaria Ag SD BIOLINE Malaria Ag Pf/Pan Wondfo One Step Malaria Pf/Pan Whole Blood Test † - Phase 2 Evaluation Panel included 90 Plasmodium spp. negative samples - 42 clean negatives; 27 samples with blood immunological abnormalities and 21 with non Plasmodium spp. infectious pathogens. RDTs - 2 tests x 2 lots at 200 parasites/μl and 1 test x 2 lots at 2000 parasites/μl *- includes pan of pv line on combination tests and pan-specific line on pan-specific only products. Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: Round 1 (2008) 27
Page 1: Malaria Rapid Diagnostic Test Perfo
Page 4 and 5: WHO Library Cataloguing-in-Publicat
Page 6 and 7: 10.3. Phase 2 - Wild type P. falcip
Page 8 and 9: Figure 24: Figure 25: Figure 26: Fi
Page 10 and 11: Table A4.5a: Distribution of Pan/Pv
Page 12 and 13: Abbreviations ACT AMI Artemisinin-b
Page 14 and 15: Figure E1: Summary performance of m
Page 16 and 17: and sometimes poor study methods, a
Page 18 and 19: 4. Materials and methods 4.1. Test
Page 20 and 21: Figure 4a: Origin of P. falciparum
Page 22 and 23: c. Ease of use assessment: After be
Page 24 and 25: 7. Ethical considerations Each spec
Page 26 and 27: 10. Results 10.1. Summary In Round
Page 28 and 29: Table 3a: Summary performance of ma
Page 30 and 31: Table 4a: Summary performance of ma
Page 32 and 33: 10.2. Phase 1 - P. falciparum cultu
Page 34 and 35: 10.3.2. P. vivax detection rate P.
Page 36 and 37: Figure 11: Phase 2 † wild type P.
Page 40 and 41: Figure 15: Plasmodium spp. (pan or
Page 42 and 43: Figure 18: Wild type P. falciparum
Page 44 and 45: 11. Heat stability A single P. falc
Page 46 and 47: Figure 25: Heat stability of pan-li
Page 48 and 49: Table 6: Ease of use description of
Page 50 and 51: 13. Discussion of key findings simu
Page 52 and 53: under field conditions, loss of par
Page 54 and 55: 14.2. Lot testing Complementary to
Page 56 and 57: 44 Malaria Rapid Diagnostic Test Pe
Page 58 and 59: Manufacturer Access Bio, Inc. ACON
Page 60 and 61: Manufacturer Innovatek Medical Inc.
Page 62 and 63: Manufacturer ICT Diagnostics Span D
Page 64 and 65: Manufacturer Product name Plasmodiu
Page 66 and 67: Type B: Malaria Generic Major Plasm
Page 68 and 69: Type D: Malaria Generic Pf-Pan RDT
Page 70 and 71: Annex 3: Phase 1 Results Table A3.1
Page 72 and 73: Table A3.2: Detection rate of 20 P.
Page 74 and 75: Table A3.3a: Distribution of test b
Page 76 and 77: P. falciparum samples (n=79) P. viv
Page 78 and 79: Table A4.2: Reader variability in d
Page 80 and 81: Table A4.4: Distribution of test ba
Page 82 and 83: Table A4.5: Distribution of pan/Pv
Page 84 and 85: 200 parasites/µl 2000 or 5000 para
Page 86 and 87: Table A4.7a: P. falciparum test lin
Page 88 and 89:
Table A4.9: False positive rate of
Page 90 and 91:
Table A4.10 False positive rate of
Page 92 and 93:
Page 94 and 95:
Page 96 and 97:
Table A4.13: Heat stability testing
Page 98 and 99:
Page 100 and 101:
Page 102 and 103:
ANNEX 5: Example algorithm for sele
Page 104 and 105:
ANNEX 6: INTRODUCING RDT-BASED MALA
Page 106 and 107:
Recommended sequence of activities
Page 110:
ISBN 978 92 4 159807 1 DOI: 10.2471
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Round 1 - Foundation for Innovative New Diagnostics

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